Insulin sensitivity in overweight/obese postmenopausal women receiving chemotherapy for breast cancer Nutritional, Metabolic, Endocrine
Conditions
Interventions
Randomisation:
Block randomization will be performed using a computer-generated random number list (e.g., https://www.randomization.com) with a 2:1 allocation using random block sizes of 2 and 4 by an
Sponsors
University of Wolverhampton
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Females who are postmenopausal (not experiencing menstrual periods for the previous 12 months via self-report) and aged between 45 and 69 years: as determined by self-report. Participants will be asked to answer whether they are pre-, peri-, or post-menopausal. If they have answered ‘post-menopausal’, they will be asked to recall when their final menstrual cycle was. 2. Diagnosed with stage I-III breast cancer with an ECOG performance status grade of 0-2 as deemed by the oncology team at the time of diagnosis. 3. Have a body mass index (BMI) of 25 to 39.9 (i.e., overweight, or obese) kg/m2, or if Asian or South Asian a BMI of 23 to 39.9 kg.m2, respectively. BMI will be taken from patient notes. 4. Scheduled to undergo chemotherapy treatment for breast cancer under oncology supervision: determined by the oncology team. 5. No medical conditions prohibiting exercise as deemed by the oncologist. 6. Not engaging in regular exercise (i.e., meeting current physical activity recommendations of at least 150 min per week of moderate exercise or at least 75 min per week of vigorous exercise, or an equivalent combination of moderate and vigorous exercise). This criterion will be assessed via the Physical Activity Vital Signs (PAVS) questionnaire, which asks the following two questions: 1) “please describe your level of physical activity, [first by] minutes per day, [followed by] number of days each week”, and 2) “at what intensity (how hard): light (like a casual walk), moderate (like a brisk walk), or vigorous (like a jog/run)?” (Ball et al., 2016). The questionnaire is scored by multiplying the days by minutes of physical activity to create an estimate of minutes per week of at least moderate-to-vigorous physical activity. This will be done verbally over the phone. 7. Able to communicate in English and able to provide and understand informed consent determined over the telephone by a trained researcher.
Exclusion criteria
Exclusion criteria: 1. Separate diagnosis of cancer within five years prior to the study (not breast cancer) as deemed by the oncology team 2. Secondary or metastatic breast cancer as deemed by the oncology team 3. Plans for reconstructive surgery during the study period expressed by the potential participant during discussions with the oncology team 4. Not fluent in written or spoken English 5. Symptoms of long COVID/post-COVID syndrome via self-report questionnaire 6. A diagnosis of type 2 diabetes or any other co-morbidity (i.e., hypertension, hypercholesterolemia, cardiovascular disease) determined via self-report 7. Taking metformin determined via self-report
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Feasibility as assessed by recruitment rate (40 patients in 12 months), retention rate (at least 70%), and adherence to exercise (at least 67% of sessions completed) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Exercise compliance measures recorded by exercise supervisors from commencement and completion of the 12-week exercise intervention. 2. Insulin sensitivity measured using an oral glucose tolerance test at baseline, post-acute exercise, and post-12-week intervention testing via blood sampling (baseline and 12-week follow-up only) and continunous glucose monitoring (all timepoints). 3. Pro- and anti-inflammatory cytokines measured using multiplex cytokine assay kits (including interleukin 6 (IL-6), IL-4, IL-10, IL-12p70, TNF-a and IFN-g) and adipokines (adiponectin, leptin and visfatin) using Luminex platform. Oestrogen (Quantikine, R&D Systems Inc., Abingdon, UK) and C-reactive protein (CRP) levels (Enzo Life Sciences, UK): Commercially available enzyme-linked immunosorbent assays (ELISA). All measured at baseline, post-acute exercise, and post-12-week intervention testing. 4. Anthropometric measures: body mass index (via measured height and mass), body fat and fat-free mass (via bioelectrical impedance), and measured waist circumference. Measured at baseline and post-12-week intervention testing. 5. Physical function tests: cardiopulmonary fitness (via a ventilatory threshold treadmill test with gas analysis), muscular strength (via a 10-repetition maximum chest press and leg press test). Measured at baseline and post-12-week intervention testing. 6. Quality of life measured using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORCT-QLQ-C30) questionnaire and its breast-specific (BR23) subscale. Measured at baseline and post-12-week intervention testing. 7. Treatment-related outcomes: chemotherapy-related adverse events, dose-limiting toxicity, time to toxicity, relative dose intensity, and chemotherapy discontinuation, termination, modifications, or delays. Adverse events (AE) will be graded according to the National Cancer Institute’s Common Terminology Criteria for Adverse Events (v5.0). Measured from base | — |
Countries
England, United Kingdom
Contacts
Public ContactIan Lahart
Outcome results
None listed